FDA will 'consider whether regulatory action is warranted on DMAA'

The Food and Drug Administration (FDA) has weighed into the debate over the stimulant DMAA (1,3-Dimethylamylamine, also known as methylhexaneamine or MHA), which has garnered more bad press in recent weeks.

The FDA was asked by NutraIngredients-USA to comment on the regulatory status of DMAA and whether this might be reviewed in light of a new probe into its safety by the US military and a lawsuit filed in California claiming USPLabs’ OxyELITE Pro and Jack3d supplements contain DMAA in a “synthetic form that is both illegal and dangerous”.

(Click here
for details on the lawsuit; click here
for details of the military probe into DMAA - launched following the death of two soldiers found to have DMAA in their blood.)

A spokesman said: “As a matter of policy, FDA does not comment on the safety, label or labeling, or claims made for products with parties other than the responsible firm during the course of any investigation for regulatory action.”

But he added: “FDA will, however, review the information contained in your email about this product.

"As with any complaint or concern we receive about FDA-regulated products, we will consider whether a violation of the Federal Food, Drug, and Cosmetic Act has occurred and, if so, whether regulatory action is warranted in light of FDA's enforcement priorities and resources.”

There is an ongoing debate about whether DMAA, which was first manufactured synthetically by drug giant Eli Lily in the 1940s, is in fact a constituent of geranium, with the consensus growing that it is not.

The American Herbal Products Association (AHPA) recently told members that they should not label DMAA as geranium oil - or as any part of the geranium plant – in their products from January 13, 2012.

Health Canada has also issued a statement arguing that DMAA is not found naturally in geranium (as many supplement makers using it claim) and affirming that any products containing it require a drug authorization.

But it is still widely used in dietary supplements sold in the US.

NSF International: DMAA is not a constituent of geranium

Ed Wyszumiala, general manager of dietary supplements programs at analytical testing firm NSF International, said: “Ifsomeone shows me the evidence proving that DMAA is extracted from geranium oil, stems or leaves, I would love to see it – and see if I can reproduce the results in my lab using the same methodology.”

But all the evidence suggested that DMAA was in fact a synthetically-produced substance that was masquerading as a ‘geranium extract’ so that firms using it in supplements could say it was an approved food flavorant, he said.

If, as seems most likely, the DMAA in question is manufactured synthetically it should go through an NDI notification to show that it is safe, he said.

The figures don’t add up

The 1996 study that is repeatedly referenced to show that DMAA is a naturally occurring constituent of geranium oil from the species Pelargonium graveolens (Ping, Z.; Jun, Q. & Qing, L. (1996), "A Study on the Chemical Constituents of Geranium Oil", Journal of Guizhou Institute of Technology 25 (1): 82–85), suggested that the raw material contained just 0.66% DMAA, said Wyszumiala.

“Let’s say hypothetically this is true, even though I haven’t seen any other published research supporting it. If the percentages are correct, you would need thousands and thousands of tons of geranium starting material to produce even a tiny quantity of DMAA.”

Quite apart from the fact that using geranium oil as a source of DMAA would appear to be cost prohibitive given current wholesale prices, it did not appear to be practical solution, he said. “You can’t go out and buy metric tons of this stuff.”

USPLabs: We stand by the safety and efficacy of our products

USPLabs said it “respectfully disagrees” with the move by the US Department of Defense to recall Jack3d, OxyElite Pro and other DMAA-containing products from military facilities amid safety concerns.

A spokesman added: "The industry is working to ensure that product availability decisions are based on sound science, and not hearsayor erroneous media reports.

"We are confident that when the facts are known, the consumers' rights to make their own educated decisions will be restored.

"We stand by the safety and efficacy of our products."

A note
published by the Defense Logistics Agency on December 7, says: "There is an ongoing review by the Department of Defense regarding potentially serious adverse health effects associated with DMAA. As a precaution, all activities are required to physically check the ingredients on all dietary supplements, weight gain, and muscle building products [sold in Army Air Force Exchange Services (AAFES) stores and other retailers on military facilities] .

"All products containing DMAA are to be pulled, and placed on medical hold. On hand inventories of products containing DMAA must be reported to accountable officers."

The Food and Drug Administration (FDA) has weighed into the debate over the stimulant DMAA (1,3-Dimethylamylamine, also known as methylhexaneamine or MHA), which has garnered more bad press in recent weeks.

2 comments(Comments are now closed)

Nutra Ingredients

This website masquerades as a pro supplement site but in fact it is anti dietary supplements. the owners of this page would prefer you have a prescription from your doctor for Multi-vitamins and pay outrageous prices for their overpriced ingredients they supply to supplement manufacturers.

Report abuse

Posted by John Smith28 December 2011 | 16h002011-12-28T16:00:48Z

FDA Labeling

Registrar Corp's Drug Labeling and Ingredient Review service helps companies determine their drug's likely classification and compliance with applicable labeling requirements. Registrar Corp cross references your labeling against thousands of pages within the Code of Federal Regulations as well as the Federal Register, CDER's Listing of OTC Active Ingredients, Rulemaking History for Nonpresciption Products, Guidance Documents and Warning Letters issued by U.S. FDA. For more information visit http://www.registrarcorp.com/fda-drugs/labeling/regulations.jsp?lang=en

Report abuse

Posted by Reggie Corpus22 December 2011 | 18h492011-12-22T18:49:45Z

Related products

On-Demand Supplier Webinar

12-Nov-2014 -
What’s hot in dietary supplements?
What’s the next break-out ingredient?
Can sports nutrition continue to flex its muscle?
What’s happening with online retailers?
Are there any regulatory hotspots to watch for?
Where’s the potential in foreign markets?
What next for GMOs and ‘natural’?
What’s on the horizon...

Application note

02-Feb-2015 - Marinova is an Australian biotechnology company dedicated to the research, development and manufacture of fucoidan extracts - complex sulfated polysaccharides derived from brown seaweed. Fucoidans are safe, natural compounds with wide ranging bioactivities that make them particularly beneficial in dietary...

Technical / white paper

18-Feb-2015 - Gone are the days when the Brand Owner or Own Label Distributor could abdicate the responsibility for the quality of their products to the Contract Manufacturing Organization. This is exactly why Gemini Pharmaceuticals
developed a Quality Partnership Program. With over...

Technical / white paper

01-Mar-2015 - InterHealth offers weight-loss ingredient brands backed by published clinical research and extensive quality testing per GLP guidelines. We know that your priority is selecting the finest weight loss ingredients on the market for your customers. You need a partner who...

Technical / white paper

16-Feb-2015 - Half of US consumers surveyed say the fiber level of a food product influences their purchase decision. This is especially true for younger people. The majority of consumers surveyed were interested in healthy, sugar-reduced food applications.

Technical / white paper

03-Feb-2015 - InterHealth’s weight-loss ingredients—Meratrim®, Super CitriMax®, 7-Keto® and LOWAT®—are backed by weight management clinical research. Thinking about formulating a non-stimulant based product? How about an appetite suppressor or an adiponectin regulator? We will collaborate with you determine which one of our...

Data sheet

22-Jan-2015 - Slimaluma is the only Caralluma Fimbriata extract clinically proven to support healthy weight management. This patented, standardized extract has a dual mechanism of action: (1) appetite suppression and (2) abdominal fat reduction. Several studies have been conducted on Slimaluma, including...

Technical / white paper

19-Jan-2015 - Scientists now understand that high-calorie, processed foods contribute to impaired glucose tolerance, which affects blood glucose metabolism, and may lie at the heart of the growing overweight population. Emerging science shows the promise of Salacia oblonga, a traditionally used herbal...

Clinical study

01-Feb-2014 - In the double-blind study, 123 participants were randomly selected to take IQP-PV-101, (Phase 2® white kidney bean extract) or a placebo. Participants taking Phase 2 lost an average of 7 pounds at the conclusion of 12 weeks and lost significantly more body...